Method and apparatus for determining blood pressure

ABSTRACT

A transducer assembly (12) is applied to the surface of the body beneath an inflatable cuff (10). Transducers (12c) are disposed upon a substrate (12a) and may include from one to some large number of transducers suitable for detecting an oscillation resulting from arterial blood flow within a partially occluded artery. Each transducer (12c) can be of large size, relative to an artery (16), to eliminate a requirement that the transducer be accurately placed over and maintained upon the artery. The substrate can be provided to have a surface with a radius of curvature selected to approximate a curvature of the extremity to which the transducer array is applied. The cuff pressure is increased to a level above the systolic pressure of the individual and then gradually reduced. Oscillations are sensed by one or more of the transducers as the cuff pressure is decreased. When the systolic pressure is reached, the sensed oscillations begin to increase in amplitude until they reach a maximum amplitude. The cuff pressure at the point of maximum amplitude is correlated with the Mean Arterial Pressure of the subject. Methods for accomplishing a sub-diastolic continuous measurement cycle and a Mean Arterial Pressure monitoring cycle are also provided.

This is a divisional of application Ser. No. 08/097,283 filed on Jul.26, 1993, now U.S. Pat. No. 5,368,039.

FIELD OF THE INVENTION

This invention relates generally to non-invasive methods and apparatusfor measuring blood pressure.

BACKGROUND OF THE INVENTION

Blood is circulated through the body by the contraction of the heart.Referring to FIG. 1, which illustrates a blood pressure wave obtained byan invasive technique, when the heart contracts it pumps blood into thearteries. This generates, typically, a maximum pressure of 120 mm Hg,which is referred to as the systolic pressure. When the contractionterminates, the pressure falls, typically, to 80 mm Hg, which isreferred to as the diastolic pressure. The dashed line, designated A,generally indicates the significantly reduced pressure waveform thatwould be measured at the surface of the skin, as opposed to within theartery itself.

The mean blood pressure, often referred to as the Mean Arterial Pressure(MAP), is an average blood pressure over the entire contraction cycle.The MAP is, however, not the average of 120 and 80, in that the bloodpressure is nearer to the diastolic pressure during most of thecontraction cycle. As a result, the MAP is typically about 90 mm. Hg.The determination of the MAP is considered to be important, in that itgenerally provides more information concerning the overall functioningof the subject's circulatory system than do measurements of only thesystolic and diastolic pressures.

The systolic and diastolic pressures are typically measured by wrappinga blood pressure cuff around an extremity containing an artery,inflating the cuff to a predetermined pressure above the systolicpressure, thereby occluding the artery, and reducing the pressuregradually allowing increased flow through the artery. Oscillationsresulting from arterial blood flow through the partially occluded arteryare sensed in some manner for an entire blood pressure measuring cycle.

The most common method for measuring blood pressure indirectly is with asphygmomanometer and stethoscope. Advantages of the sphygmomanometer andstethoscope include simplicity and low cost. However, the procedure isrelatively inaccurate, and produces only a limited amount of diagnosticinformation.

The procedure by which a sphygmomanometer is utilized to determine bloodpressure is relatively simple. A collapsed, inflatable blood pressurecuff is first placed around a subject's arm. Pressure in the cuff isthen increased to a level of about 30 mm. Hg. above a point at which thepalpable pulse disappears. As the cuff is deflated, observations may bemade either by palpation or auscultation. The point at which the pulsecan be felt is recorded from the manometer as the systolic pressure.

The auscultatory method is usually preferred to the technique describedabove. With this method, vibrations from the artery under pressure,called Korotkoff sounds, are used as indicators.

To determine blood pressure using the auscultatory method, the bell ordiaphragm of a stethoscope is pressed lightly over a brachial arterywhile the cuff is slowly deflated. The pressure readings begin at thetime the Korotkoff sounds first become audible. As the cuff is deflatedfurther, the sounds become louder for a brief period. The sounds thenbecome muffled and finally disappear. The systolic blood pressure is thepoint at which the Korotkoff sounds become audible, and the diastolicblood pressure is the point at which the sounds cease to be heard.

There are several other known methods for accomplishing the measuring ofthe systolic and the diastolic pressures. Two conventional methods, thatrely on the use of electronic components, are known in the art asoscillometry and tonometry.

In oscillometry, the oscillations resulting from arterial blood flowthrough the partially occluded artery are transmitted as pressurevariations through the cuff and tubings to a sensitive pressuretransducer located within a monitor. However, in that the pressuretransducer must be highly sensitive, the slightest movement of thesubject can give rise artifacts which reduce the accuracy of themeasurement. As a result, artifact detection and rejection circuits maybe required to be included within the monitor. Furthermore, theoscillometric method typically requires a stepwise reduction of cuffpressure. In addition, blood pressure measurement may not be possible atall if the subject's blood pressure is below a threshold value.

In tonometry a transducer is placed directly over a superficial artery,such as the radial artery, and is compressed against an underlying bonewith a predetermined pressure. Oscillations resulting from arterialblood flow through the artery are converted to electrical signals by thetransducer and are subsequently detected. In practice, the transducer issmaller than the diameter of the artery. As a result, the tonometricsensor must be positioned very accurately over the artery, and must alsopartially compress the artery. As a result, even a small misalignmentmakes it difficult or impossible to accurately measure blood pressure.Furthermore, accurate calibration of the tonometric system is typicallynecessary.

U.S. Pat. No. 4,427,013 describes the use of a determination of anincrease and a decrease in the rate of a rise and a fall, respectively,of a blood pressure waveform to determine the systolic and the diastolicpressures. In U.S. Pat. No. 4,860,760 there is described the use of afirst fixed threshold, referenced to a peak blood pressure, to indicatethe systolic pressure, and a second fixed threshold to indicate thediastolic pressure.

These and other U.S. Patents of interest to the teaching of thisinvention are described below.

U.S. Pat. No. 5,031,630, issued Jul. 16, 1991, entitled Automatic BloodPressure Measuring Apparatus, describes a cuff 10 having sixpiezoelectric sheets 18-28 disposed on a cuff surface that contacts thebody of the patient. Sheets 18-22 are arranged to detect proximal arterysounds, while sheets 24-28 are located to detect Korotkoff soundstransmitted from the artery to a middle area of the cuff (col. 3, line48-col. 4, line 3). Signals generated by the sheets 18-28 are digitizedand applied to a CPU 34, as is the output of a cuff pressure sensor 36(col. 4, lines 4-24). The sheets (18-22) are monitored to select anoptimum sensing sheet, after which the sheet (24-26) that is alignedwith the selected sheet (18-22) is also selected (col. 5, lines 14-44).The selected piezoelectric sheets are used to monitor Korotkoff sounds,which are used in conjunction with cuff pressure to determine bloodpressure (col. 6, lines 4-48). The size of the individual (cuff-mounted)piezoelectric sheets is not disclosed (i.e., whether they are smaller orlarger than the artery).

U.S. Pat. No. 5,165,416, issued Nov. 24, 1992, entitled "ContinuousBlood Pressure Monitoring System Having a Digital Cuff CalibrationSystem and Method", describes the use of a tonometric sensor 10 and adigital cuff 20. Both the sensor 10 and cuff 20 receive a pressurizedfluid (col. 2, lines 53-54). The cuff 20 is positioned downstream ofsensor 10 (col. 4, lines 38-42). A calibration sensor 22 can be added tothe cuff 20. The sensor 22 can be a microphone for detecting Korotkoffsounds, or may be an optical sensor (col. 4, lines 47-57).

U.S. Pat. No. 4,880,013, issued Nov. 14, 1989, entitled "Method andApparatus For Determining Blood Pressure and Cardiovascular Condition"describes the use of a pressure transducer 16 and a cuff 10. Both aresaid to be affixed to the patent (col. 4, lines 36-37). A data stream isobtained from the pressure transducer 16, the data stream including bothpressure data and pulsation signal data. Systolic maximum points anddiastolic minimum points are determined. Two methods of determining MeanArterial Pressure (MAP) are also disclosed; specifically a "midpointmethod" and a "mathematical calculation method". A procedure foroperating the cuff and pressure transducer is described at col. 11,lines 5-65. It is noted that this patent does not provide any specificsas to how and where the transducer is affixed to the patient. At col. 8,lines 32-36 it is stated that the pressure transducer may be thatsupplied with a known type of blood pressure monitor. As indicated atcol. 3, lines 6-23, this known type of device appears to operate on theoscillometric, as opposed to the tonometric, principle.

U.S. Pat. No. 4,295,471, issued Oct. 20, 1981, entitled "Non-InvasiveVascular Waveform Transducer and Apparatus" describes the use of aninflatable cuff 10 that includes a transducer 30. The transducer islocated near a blood vessel to be monitored when the cuff is installed(col. 3, lines 53-62). The transducer 30 is used to detect Korotkoffsounds as the cuff is deflated (col. 4, lines 7-12). A dual sensingapproach, described at col. 5, lines 21-40, is used to reject commonmode signals (col. 5, line 54 to col. 6, line 16). The determination ofMAP is described at col. 14, lines 38-54. A continuous display of anarterial waveform is described at col. 15, line 64 to col. 16, line 12.All embodiments of the transducer 10 appear to be circular in shape(FIGS. 2a, 5a, 5b, 5c), and not shaped to generally conform to theextremity of the patient.

U.S. Pat. No. 5,103,830, issued Apr. 14, 1992, entitled "ElectronicSphygmomanometer", describes an electronic sphygmomanometer that usesboth the Korotkoff and the oscillometric methods. A cuff 1 has aKorotkoff sound sensor disposed on a "periphery" of the cuff (col. 6,lines 10-23), and a pressure sensor 21 is connected to the cuff 1.

U.S. Pat. No. 4,653,506, issued Mar. 31, 1987, entitled "Method ofIndirect Measurement of Arterial Tension and a Device for Pulse WaveRegistration", describes the use of a cuff 3 under which a device 9 isapplied to a patient's body. The passing of a blood pulse wave under thedevice 9 is converted to an electrical signal by a piezo-sensitive cell17 (col. 6, liens 13-19). Cuff pressure is monitored by a pressure gauge11. The cuff pressure does not appear to be converted to an electricalsignal, and no means is disclosed for correlating signals received fromthe device 9 with cuff pressure.

U.S. Pat. No. 4,951,679, issued Aug. 28, 1990, entitled "Pulse WaveDetecting Apparatus Having Placement-Condition Detecting Means",describes a tonometric-type device that includes a pulse wave detectingprobe 16 that is fixed with a band 14 fastened around a patient's arm.The probe 16 is pressurized with a fluid for urging a diaphragm 22toward the surface of the arm (col. 3, line 37 to col. 4, line 9).

U.S. Pat. No. 5,033,471, issued Aug. 23, 1991, entitled "Method andApparatus Measuring Blood Pressure", is also directed to atonometric-type device that appears to be similar to that describedabove with respect to U.S. Pat. No. 4,951,679 (see col. 6, line 56 tocol. 7, line 55).

U.S. Pat. No. 5,172,696, issued Dec. 22, 1992, entitled "PhotoelectricSphygmomanometer of Volume Oscillometric Method-Type", describes aphotoelectric sphygmomanometer of a "volume oscillometric" type. A cuff1 is fastened to the wrist or fingertip of a patient. A pressure sensor6 senses cuff pressure. A pulsation sensor 8, located inside the cuff,includes a LED 8a and phototransistor 8b for irradiating arterial bloodand detecting light reflected from the arterial blood, respectively(col. 4, lines 10-36). Measurements of cuff pressure and pulsationsignals are used to determine systolic, diastolic, and mean bloodpressure (col. 8, lines 14-26). The use of a tonometric, under-cuffsensor, that may be shaped to conform to the extremity of the patient,is not disclosed.

U.S. Pat. No. 4,924,871, issued May 15, 1990, entitled "Motion ArtifactDetection for Continuous Blood Pressure Monitor Transducer", describes atonometric-type device that includes an array of individual pressuresensitive transducers 22A-22E, all of which are small relative to thediameter of an artery (FIG. 4, col. 3, line 59-col. 4, line 22). Achange in pressure within a pressurizable chamber 40 is detected andinterpreted to indicate motion of the patient. When motion is detected,data collection is interrupted (col. 5, line 55 to col. 6, line 31).

U.S. Pat. No. 4,860,760, issued Aug. 29, 1989, entitled "ElectronicBlood Pressure Meter Incorporating Compensation Function for Systolicand Diastolic Blood Pressure Determinations", describes anoscillometric-type device wherein a cuff 2 is connected to a pressuresensor 11 (col. 10, lines 16-66).

Also of interest is U.S. Pat. No. 3,527,204, issued Sep. 8, 1970, whichdescribes at col. 4, lines 6-10 the use of a transducer 111 which may bea microphone. The microphone is said to be placed under a cuff whenblood pressure is measured using an auscultatory method.

Other patents of interest to this invention include the following. Afirst group of patents are generally related to oscillometric-typedeterminations: U.S. Pat. Nos. 5,001,187, 4,427,013, 3,903,872 (whichprovides a cuff-mounted pressure transducer), 4,543,962, 4,349,034,4,009,709, 4,984,577, 4,995,399 and 4,074,711. A second group of patentsare generally related to tonometric-type determinations: U.S. Pat. Nos.3,880,145, 4,269,193, 4,223,738, 4,987,900, and 5,005,581 (all of whichemploy multiple sensors). Also of interest are U.S. Pat. Nos. 4,993,422,3,102,534, 3,123,068, 3,154,067 (which provides a strain gauge),3,903,873, 3,926,179, 4,185,621, 4,034,484 and 4,307,727.

Also of interest is a pulse rate monitor shown in U.S. Pat. Nos.4,489,731, a cuff-less blood pressure measuring device shown in4,068,654, and the systems described in the Abstracts of WO 79/00294 andWO 88/03777.

An invasive blood pressure measuring system that is capable of measuringthe mean arterial pressure is described in U.S. Pat. No. 3,893,452.

Also of interest is an article entitled "Evaluation of ArterialTonometry for Noninvasive Continuous Blood Pressure Monitoring DuringAnesthesia", Anesthesiology, V71, No. 3A, September 1989 (O. Kemmotsu,et al.); an article entitled "Arterial Tonometry: Review and Analysis",J. Biomechanics, Vol. 16, No. 2, pp. 141-152, 1983 (Gary M. Drzewiecki,et al.); an article entitled "The Meaning of the Point of MaximumOscillations in Cuff Pressure in the Indirect Measurement of BloodPressure, Part I.", Cardiovascular Research Center Bulletin, Vol. 8, No.1, July-September, 1969 (J. A. Posey, et al.); an article entitled"Characterization of the Oscillometric Method for Measuring IndirectBlood Pressure", Annals of Biomedical Engineering, Vol. 10, pp. 271-283,1982 (L. A. Geddes, et al.); an article entitled "The IndirectMeasurement of Mean Blood Pressure in the Horse", The SouthwesternVeterinarian, pp. 289-293, Summer 1970 (L. A. Geddes, et al.); and anarticle entitled "A Transducer for the Continuous External Measurementof Arterial Blood Pressure", IEEE Transactions on Bio-MedicalElectronics", pp. 73-81, 1963, (G. L. Pressman et al.).

SUMMARY OF THE INVENTION

It is one object of this invention to provide a non-invasive method andapparatus and method that overcomes the problems encountered with theuse of both the oscillometric and tonometric approaches.

It is another object of this invention to provide a non-invasive methodand apparatus and method that combines elements from the oscillometricand tonometric approaches to yield a technique that is superior to both.

It is a further object of this invention to provide a transducerassembly for use in obtaining a blood pressure measurement, thetransducer assembly being comprised of a substrate having a curvedsurface and one or more pressure transducers located on the curvedsurface.

It is another object of this invention to provide a method to determinethe Mean Arterial Pressure of a subject in a non-invasive and accuratemanner.

A further object of this invention is to provide a non-invasivetechnique to monitor the Mean Arterial Pressure over a period of time.

A still further object of this invention is to provide a non-invasivetechnique to monitor the blood pressure over an extended period of time,while employing a cuff pressure that is less than the diastolic pressureof a subject.

The above-described and other problems are overcome, and the objects arerealized, by an apparatus and methods for measuring blood pressure inaccordance with the teaching of this invention. The apparatus includes apressure sensing device or transducer that is placed over the skin of anextremity near an artery. For example, the transducer may be placed onthe upper arm near the brachial artery. An inflatable cuff is wrappedaround the extremity over the sensor in a manner similar to theapplication of a conventional blood pressure cuff.

Operation includes inflating of the cuff to a predetermined pressure,and then correlating the cuff pressure to the amplitude of oscillationsmeasured by the transducer while the cuff pressure is gradually reducedfrom a level above the systolic to below the diastolic pressure. Thecuff pressure at which the amplitude of oscillations is a maximum iscorrelated with the MAP. The systolic and diastolic pressures aredetermined, in a first embodiment of the invention, by comparingmeasured oscillation amplitudes with other measured amplitudes whileadding or subtracting, respectively, a predetermined amplitudeincrement.

In another embodiment of the invention the oscillations are collectedover an entire blood pressure measurement cycle, a maximum oscillationamplitude is determined, the systolic and diastolic pressures aredetermined by correlating the cuff pressure at points where oscillationsare within a predetermined percentage of the maximum amplitude, and theMean Arterial Pressure is determined by correlating the cuff pressure atthe time of the oscillation having the maximum amplitude.

The blood pressure measurement is made non-invasively, that is, thetransducer comes into contact with the surface of the body but does notpenetrate the skin into deeper body tissues.

The present invention provides an apparatus and a method of determiningblood pressure by applying a blood pressure cuff around an extremitycontaining an artery, inflating the cuff to a predetermined pressureabove the systolic pressure, thereby occluding the artery, and reducingthe pressure gradually allowing increased flow through the artery.

A transducer array is first applied to the surface of the body beneaththe cuff. The transducer array is disposed upon a substrate and mayinclude from one to some large number of transducers suitable fordetecting an oscillation resulting from arterial blood flow within apartially occluded artery. Each transducer is preferably of large size,relative to the artery, to eliminate a requirement that the transducerbe accurately placed over and maintained upon the artery. The substratemay be provided to have a surface with a radius of curvature selected toapproximate a curvature of the extremity to which the transducer arrayis applied.

The cuff pressure is increased to a level above the systolic pressure ofthe individual and then gradually reduced. Oscillations are sensed byone or more of the transducers of the transducer array as the cuffpressure is decreased. When the systolic pressure is reached, the sensedoscillations begin to increase in amplitude until they reach a maximumamplitude. The cuff pressure at the point of maximum amplitude iscorrelated with the MAP of the subject. The amplitude of theoscillations then begin to decrease until the cuff pressure isapproximately equal to the diastolic blood pressure, at which time theoscillations fall below a predetermined minimum amplitude.

The cuff pressure and the amplitude of oscillations may be registered bya monitor for an entire blood pressure monitoring cycle for subsequentanalysis. Alternatively, the analysis may be carried out in real time,i.e., during the blood pressure measurement cycle. In either case, thecuff pressure at the maximum amplitude of oscillations is determined andreported as the mean arterial blood pressure.

The teaching of this invention is also extendable to the continuousmeasurement of blood pressure over an interval that is generallysignificantly longer than that for a single measurement cycle, and alsoto the continuous determination and monitoring of the mean arterialpressure.

BRIEF DESCRIPTION OF THE DRAWINGS

The above set forth and other features of the invention are made moreapparent in the ensuing Detailed Description of the Invention when readin conjunction with the attached Drawings, wherein:

FIG. 1 is graph that depicts the variation in blood pressure over time,when measured with an invasive pressure sensor;

FIG. 2 illustrates a transducer assembly of the invention disposedbeneath an inflatable cuff;

FIG. 3a is an elevational view illustrating the transducer assembly ofFIG. 2;

FIG. 3b is an end view of the transducer assembly of FIG. 3a;

FIG. 4 is a graph that illustrates a blood pressure measurement cycle inaccordance with the invention;

FIG. 5 is a block diagram of apparatus constructed in accordance withthe invention for interfacing to the cuff and transducer assembly ofFIG. 2;

FIG. 6 is a flow chart that illustrates one embodiment of a method foroperating the processor of FIG. 5 during the measurement of bloodpressure;

FIG. 7 is a flow chart that illustrates another embodiment of a methodfor operating the processor of FIG. 5 during the measurement of bloodpressure;

FIG. 8 depicts an exemplary cuff pressure variation cycle about thedetermined MAP, when executing a method of continuous MAP monitoring;

FIGS. 9a-9c are three examples corresponding to the cuff pressurevariation cycle of FIG. 8; and

FIG. 10 illustrates a method of continuous blood pressure determinationfor a cuff pressure that is maintained at a pressure less than thediastolic pressure.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 2 in conjunction with FIG. 5, an inflatable cuff 10and a transducer assembly 12 are affixed to, typically, an arm 14 of asubject. The transducer assembly 12 is positioned so as to be in thegeneral vicinity of, and to generally overlie, the brachial artery 16.The cuff 10 is connected to a pump 18 by a conduit 10a whereby the pump18 is enabled to pressurize and depressurize the cuff 10. Pressurizationis accomplished with a compressible fluid, typically air. Outputs of thetransducer assembly 12 are connected to a multiplexer (MUX) 20 via acable 12a.

As is seen more clearly in FIG. 3a, in one embodiment of the inventionthe transducer assembly 12 is comprised of a curved substrate 12b towhich are affixed, on a concave surface thereof, a plurality oftransducers 12c. Transducers 12c are preferably piezoelectric devicesthat generate a detectable voltage potential upon an application of astrain. During use, the strain is generated by the oscillations of thearterial blood flow through the partially occluded brachial artery 16.The generated voltage potential is conveyed from a given one of thetransducers 12c by an associated conductor 12d that runs through thecable 12a to an input of the multiplexer 20.

In general, the response time of each transducer 12c is less than orequal to approximately 0.001 seconds, and the frequency response iswithin a range of approximately 0.2 Hz to approximately 50 Hz.

The apparatus of FIGS. 2 and 5 operates under the control of a processor22, such as a microprocessor. As such, a memory 24 is bidirectionallycoupled to the processor 22. The memory 24 contains a stored program forcontrolling the processor 22 to operate the apparatus in accordance withthe methods of this invention, as illustrated in the flow charts ofFIGS. 6 and 7. The processor 22 is also enabled to store data within,and retrieve data from, the memory 24 during the execution of the storedprogram. It should be realized that the memory 24 could be containedwithin the processor 22, and may not be a separately provided component.

The processor 22 is interfaced to the pump 18 via a pressure controlsignal line 18a. The processor 22 is thereby enabled to operate the pump18 so as to controllably pressurize and depressurize the cuff 10. Ameasured pressure signal line 18b is provided from the pump 18 to aninput of the processor 22 whereby the processor 22 is enabled todetermine at any time the pressure that is being exerted upon thecompressible fluid that pressurizes the cuff 10.

The processor 22 is also interfaced to the multiplexer 20 via a MUXaddress signal line 20a whereby the processor 22 is enabled to specify aparticular one of the plurality of conductors 12d that is to be coupledfrom the input of the multiplexer 20 to an output 20b. In this mannerthe voltage potential appearing on a specified one of the plurality ofthe conductors 12d is passed through the multiplexer 20 to the output20b.

Coupled to the output 20b is an analog to digital convertor (A/D) 26.A/D 26 operates in a conventional fashion to convert, in response to anactivation of a SAMPLE signal line 26a, the voltage potential appearingat the input to a multi-bit digital output (D0-Dn). The value of n is afunction of the desired measurement resolution. An eight bit output(n=7) is generally suitable for most applications. If required, anamplifier (not shown) may be interposed between the output of the MUX 20and the input of the A/D 26. Alternately, an amplifier (not shown) maybe provided for each of the inputs 12d before connection to the input ofthe MUX 20.

The digital output from A/D 26 is applied to a digital input port of theprocessor 22, thereby enabling the processor 22 to determine a magnitudeof a voltage potential being generated by a particular one of thetransducers 12c, as specified by the value of the MUX address 20a. Themagnitude of the voltage potential indicates the magnitude of theoscillation resulting from the arterial blood flow through the partiallyoccluded brachial artery 16. Such oscillations occur at a rate that isequal to the heart beat rate of the subject. The sampling rate of A/D 26is set by the processor 22 so as to ensure that undersampling of thearterial pressure pulse does not occur, and that a sufficient number ofsamples are taken during an oscillation to enable a maximum amplitude ofthe oscillation to be determined.

The processor 22 is also bidirectionally coupled to a user interface 28whereby the results of a blood pressure measurement cycle may bedisplayed to an operator, and whereby the operator is enabled toinitiate a blood pressure measurement cycle. As an example, the userinterface 28 includes an alphanumeric display 28a, such as an LED or LCDdisplay, whereon the determined systolic (S) blood pressure, thedetermined diastolic (D) blood pressure, the determined mean arterialpressure (MAP), and the measured pulse rate (P) are displayed to theoperator. The user interface 28 may also include a CRT or LCD display28b for visually indicating in a graphical fashion the amplitudes of theoscillations measured by a selected one or ones of the transducers 12c.Also provided on the user interface 28 are switches 28c whereby theoperator is enabled to, for example, initiate a single blood pressuremeasurement cycle, or specify that a continuous blood pressuremeasurement cycle be initiated.

In operation, and referring to a first method illustrated in the flowchart of FIG. 6 in conjunction with the graph of FIG. 4, the processor22 idles in a loop waiting for operator input to initiate a bloodpressure measurement cycle (Block A). If Yes at Block A, control passesto Block B wherein the processor 22 commands the pump 18 to pressurizethe cuff 10 to a pressure that exceeds the normal systolic pressure. Forexample, the pump 18 is commanded, via pressure control signal line 18a,to pressurize the cuff 10 to a pressure that exceeds the typicalsystolic pressure by 30 mm.Hg. When the cuff is fully pressurized, thebrachial artery 16 is completely occluded and no oscillations are sensedby any of the transducers 12c. At Block C the processor 22 commands thepump 18 to begin depressurizing the cuff 10. The cuff 10 may bedepressurized in increments of pressure, such as 5 mm.Hg., or may bedepressurized in a continuous fashion without significant pressuresteps. At Block D the processor 22 reads individual ones of thetransducers 12c until detectable signals are obtained from at least oneof the transducers 12c, as indicated by the oscillation (aa) in thelower trace of FIG. 4. Each oscillation shown in the lower tracecorresponds to one heart beat (HB). The detection of a signal indicatesthat the presently specified transducer is positioned sufficiently nearto the brachial artery 16 so as to respond to the pulsation of arterialblood flow in the now partially occluded brachial artery. At Block E theprocessor 22 selects a transducer 12c having a highest amplitude signal,it being assumed that the selected transducer is optimally positionedfor detecting the arterial blood pulsations. The method operates in aloop and continues to execute Blocks C and D until a suitable transduceris selected. Typically, the suitable transducer is selected as thetransducer that indicates the highest amplitude of oscillation.

It is noted that after the initial oscillation (aa) is detected, it maybe desirable to halt the decompression of the cuff 10 while scanning allof the transducers 12c to determine the transducer that is detecting thegreatest amplitude of oscillation. In this manner the outputs of thetransducers 12c are compared to one another while a constant compressiveforce is applied to the brachial artery.

The operation of the processor 22 at Blocks C, D, and E is facilitatedby the construction of the transducer assembly 12 in accordance with anaspect of this invention. More specifically, the provision of aplurality of transducers 12c at various positions on the concave surfaceof the substrate 12a ensures that at least one transducer will bepositioned at a location, relative to the brachial artery 16, fordetecting arterial blood pulsations. Furthermore, each transducer 12cmay have dimensions that are selected to be larger than the diameter ofthe brachial artery 16. By example, each transducer 12c can be providedwith linear dimensions of approximately two centimeters when used with abrachial artery having a diameter of one centimeter. This use ofrelatively large transducers overcomes the constraints imposed on manyconventional tonometric type systems that employ one or more smalltransducers that must be accurately and precisely positioned over anartery of interest, and maintained in that position during themeasurement. However, the use of one or more transducers havingdimensions that are equal to or smaller than the artery is also withinthe scope of this invention.

In addition, and in accordance with an aspect of this invention, thesubstrate 12a may be provided with a radius of curvature (r), as bestseen in FIG. 3b, that is selected to correspond to the curvature of thelimb to which the transducer assembly 12 is applied. The substrate 12ais thus preferably comprised of a non-electrically conductive rigid orsemi-rigid material, such as a thermoplastic, so as to maintain theradius of curvature. The use of a semi-rigid material enables thecurvature of the substrate 12a to change as a result of the compressiveforce exerted by the cuff, and to thus accommodate itself to thecurvature of the limb.

In accordance with this aspect of the invention, various transducerassemblies may be provided, thereby enabling the operator to select atransducer assembly having a radius of curvature that best matches thecurvature of the limb of the subject. As such, a number of transducerassemblies 12 may be provided, differing from one another by the radiusof curvature, for use with children and adults within various weightranges. Of course, the size of the individual transducers 12c may bescaled accordingly, in that the brachial artery will differ in diameterbetween, by example, an adult male and a small child.

However, if desired the substrate could be comprised of a flexiblematerial that is wrapped totally or partially about the limb. In likemanner, the substrate may comprise the inner wall of the cuff 10.

Having acquired an optimal one of the transducers 12c at Blocks C-D-E,the method then executes Blocks F-G-H where the selected transducer ismonitored, while continuing to deflate the cuff 10, until the amplitudeof oscillation rises to a value that exceeds the initial value ofoscillation (aa) by a predetermined first increment ΔI₁ (FIG. 4). As anexample, the predetermined first increment may be 100% of the amplitudeof the oscillation (aa).

More particularly, Blocks F-G-H are a monitoring loop wherein theprocessor 22 continues to reduce the cuff pressure while detecting themaximum amplitude of each successive oscillation recorded by theselected transducer 12c (Block F). When the maximum amplitude of anoscillation is detected, the processor 22 records the pressure of thecuff 10 at the time of maximum amplitude and the time at which themaximum amplitude occurred (Block G). For a given oscillation (OSC_(n)),the processor 22 compares at Block H the maximum amplitude to the sum ofthe maximum amplitude of oscillation OSC_(n-1) and the predeterminedfirst increment ΔI₁. If the maximum amplitude of oscillation OSC_(n) isless than the maximum amplitude of the previous oscillation, plus thepredetermined first increment, control returns to Block F. If the resultof the comparison at Block H indicates Yes, then control passes to BlockJ. This will occur for the oscillation (bb).

The oscillation identified as exceeding the initial oscillation by thepredetermined first increment (designated as (bb)) is recorded, and atBlock J the cuff pressure recorded for the maximum amplitude ofoscillation (bb) is stored as the systolic pressure (S).

Blocks K-L-M are a monitoring loop wherein the processor 22 continues toreduce the cuff pressure while detecting the maximum amplitude of eachsuccessive oscillation recorded by the selected transducer 12c (BlockK). When the maximum amplitude of an oscillation is detected, theprocessor 22 records the pressure of the cuff 10 at the time of maximumamplitude and the time at which the maximum amplitude occurred (BlockL). For a given oscillation (OSC_(n)), the processor 22 compares atBlock M the maximum amplitude to the maximum amplitude recorded for thepreceding oscillation (OSC_(n-1)). If the maximum amplitude ofoscillation (OSC_(n)) is greater than the maximum amplitude ofoscillation (OSC_(n-1)), the control returns to Block K. Such would bethe case for oscillations (cc), (dd), (ee) and (ff) of FIG. 4. If theresult of the comparison at Block M indicates Yes, indicating that themost recent oscillation has a amplitude that is less than the amplitudeof the preceding oscillation, then control passes to Block N. This willoccur for the oscillation (gg).

At Block N the processor 22 recalls the cuff pressure that was recordedwhen the maximum amplitude of oscillation (ff) was detected. Therecalled cuff pressure is stored as the Mean Arterial Pressure (MAP).That is, the cuff pressure that corresponds to the oscillation having agreatest maximum amplitude is correlated with the MAP.

Blocks O-P-Q are also a monitoring loop wherein the processor 22continues to reduce the cuff pressure while detecting the maximumamplitude of each successive oscillation recorded by the selectedtransducer 12c (Block O). When the maximum amplitude of an oscillationis detected, the processor 22 records the pressure of the cuff 10 at thetime of maximum amplitude and the time at which the maximum amplitudeoccurred (Block P). For a given oscillation (OSC_(n)), the processor 22compares at Block Q the maximum amplitude to the difference between themaximum amplitude of oscillation OSC_(n-1) and the predetermined secondincrement ΔI₂. If the maximum amplitude of oscillation OSC_(n) isgreater than the maximum amplitude of the previous oscillation, minusthe predetermined second increment, control returns to Block O. If theresult of the comparison at Block I indicates Yes, then control passesto Block R.

This will occur for the oscillation (ii). As an example, thepredetermined second increment may be 100% of the amplitude of thepreceding oscillation, in this case the oscillation (hh).

The oscillation identified as being less than the previous oscillationby the predetermined second increment is recorded, and at Block R thecuff pressure recorded for the maximum amplitude of oscillation (hh) isstored as the diastolic pressure (D).

At Block S the processor 22 recalls the stored systolic (S), MAP, anddiastolic (D) pressures and provides them to the alphanumeric display28a of the user interface 28. The processor 22 is also enabled, based onthe recorded times that maximum oscillation amplitudes occurred, todetermine the pulse rate (P) and to also provide the pulse rate to theuser interface 28. By example, an average of the times between adjacentpeak amplitudes is determined, and the result is divided into 60seconds. If desired, the processor 22 can also recall the stored maximumamplitudes of the oscillations, suitably scale same in amplitude andtime, and generate the graphical display for the CRT or LCD display 28b.

FIG. 7 depicts a further method in accordance with the teaching of thisinvention. Blocks A-E are performed identically to Blocks A-E of FIG. 6so as to select a suitable one of the transducers 12c. At Block F theprocessor 22 monitors the output of the selected transducer for theentire blood pressure measurement cycle so as to detect and store themaximum amplitude, and the time of occurrence, for each pressureoscillation. When a maximum amplitude is detected, the cuff pressure ismeasured and stored. At Block G the oscillation having the largeststored maximum amplitude is determined, and the corresponding storedcuff pressure is correlated with the MAP. Next, at Block H apredetermined percentage of the maximum oscillation amplitude, such as50%, is determined, and a cuff pressure corresponding to the pressurepulse having a maximum amplitude that is within a predetermined range ofthe percentage is correlated with the systolic pressure. If no pressurepulse has a maximum amplitude within the predetermined range, then twoadjacent pulses that bracket the percentage can be employed, and thecuff pressure is extrapolated from the cuff pressures corresponding tothe two adjacent pulses. Instead of using a fixed percentage, adetermination of a change in a rate of change of the maximum pulseamplitudes can be employed instead.

At Block I a predetermined percentage of the maximum oscillationamplitude, such as 50%, is determined, and a cuff pressure correspondingto the pressure pulse having a maximum amplitude that is within apredetermined range of the percentage is correlated with the diastolicpressure. As in Block H, if no pressure pulse has a maximum amplitudewithin the predetermined range, then two adjacent pulses that bracketthe percentage can be employed, and the cuff pressure is extrapolatedfrom the cuff pressures corresponding to the two adjacent pulses. Alsoas in Block H, a determination of a change in a rate of change of themaximum pulse amplitudes can be employed instead of the fixedpercentage.

At Block J the results are displayed, as in Block S of FIG. 6. The pulserate may also be determined and displayed, as previously described.

It can be appreciated that the method of FIG. 6 enables operation inreal time during a blood pressure measurement cycle, whereas the methodof FIG. 7 accumulates readings over the measurement cycle and thensubsequently determines the MAP, systolic, and diastolic pressures.

It is within the scope of the invention to temporarily maintain the cuffpressure within a range of pressures, for example ±10%, about thepressure that correlates with the MAP determined at Block N of FIG. 6 orBlock G of FIG. 7, and to continually update the display 28a, for eachheart beat, with the MAP. That is, the processor 22 operates in a loopso as to vary the cuff pressure to obtain oscillations having a maximumamplitude. As a result, the MAP is determined and displayed for eachheart beat over a period of time. This mode of operation can be enteredin response to one of the switches 28c.

In this mode of operation, either the method of FIG. 6 or FIG. 7 isfirst executed so as to determine the MAP. After this calibrationprocedure, the cuff 10 is inflated to the pressure that corresponds tothe determined MAP, and the cuff pressure is then slowly varied aboveand below the determined MAP pressure (FIG. 8) while the processor 22determines the maximum amplitude of the pressure pulses received fromthe selected transducer 12c. The frequency of the pressure variation isselected to be significantly less than the heart rate. For example, fora heart rate of 60 beats per minute a suitable frequency of cuffpressure variation is 0.2 Hz. For each determined pressure pulse ofgreatest maximum amplitude, the corresponding cuff pressure is reportedas the MAP. This mode of operation can be especially beneficial during asurgical procedure, in that it enables the continuous determination andmonitoring of the MAP over an interval of time that is longer than atypical blood pressure measurement interval.

FIGS. 9a-9c are an example where the MAP baseline pressure is 80 mm Hg,and wherein the cuff pressure is varied plus and minus ten percentaround the MAP baseline pressure (72 mm Hg to 88 mm Hg).

FIG. 9a illustrates the case where the MAP remains substantiallyconstant. As can be seen, the greatest maximum amplitude of the pressurepulses occur for a cuff pressure of 80 mm Hg. At other cuff pressuresthe maximum amplitudes of the pressure pulses are reduced. Thisreduction in maximum amplitude of the pressure pulses above and belowthe MAP pressure corresponds to, by example, the reduced amplitudes ofthe pulses (ee) and (gg), respectively, that bracket the pulse (ff) inFIG. 4.

FIG. 9b illustrates the case where the MAP has increased from theoriginally established baseline pressure, while FIG. 9c illustrates thecase where the MAP has decreased from the originally establishedbaseline pressure. In both of these cases the MAP remains within theplus and minus 10 percent cuff pressure variation. The processor 22 isenabled to detect this change in MAP over several pressure pulses and,if desired, shift the baseline pressure either upwardly or downwardly soas to correspond to the new value of MAP.

If the MAP changes during the monitoring period, such that it lies aboveor below the varying range of cuff pressures, the cuff 10 can bedeflated and another measurement cycle (FIG. 6 or 7) initiated, eithermanually or automatically, so as to determine the new value of MAP. Thecuff 10 is then inflated to the newly determined MAP pressure and thecontinuous MAP measurement cycle is re-initiated.

Alternatively, the processor 22 is operable to incrementally vary thebaseline cuff pressure either upwardly or downwardly so as toaccommodate a sudden increase or decrease in the MAP, without executinga calibration measurement cycle. For either technique, it may also bedesirable to provide an audible and/or visual indication at the userinterface 28 to notify an operator of the sudden change in the MAP.

It is also within the scope of the invention to provide a continuousindication of blood pressure by inflating the cuff 10 at low pressuresand then sensing the oscillations with the transducer assembly 12. Theamplitude of the oscillations are proportional to the arterial bloodpressure.

In this mode of operation either the method of FIG. 6 or FIG. 7 is firstexecuted so as to determine at least the systolic and the diastolicblood pressures. After this calibration procedure, the cuff 10 isinflated to a pressure that is less than the determined diastolicpressure. The cuff pressure is then maintained at this level while theprocessor 22 determines the maximum amplitude of the pressure pulsesreceived from the selected transducer 12c (FIG. 10). The cuff pressureis preferably maintained above the venous pressure (normally below 15Torr) and below the determined diastolic pressure. The maximumamplitudes of the pressure pulses are recorded, now significantlyreduced due to the reduction in cuff pressure below the diastolicpressure, and are correlated with, by example, the previously measuredsystolic pressure. As seen in FIG. 10, the pulses A, B, and C are all ofapproximately the same amplitude and are correlated with the previouslymeasured systolic pressure of, by example, 130 mm Hg. At a subsequenttime the maximum measured amplitude increases (pulse D). The percentagechange (+Δa) is translated into a corresponding percentage increase inthe systolic pressure of from, for example, 130 mm Hg to 145 mm Hg, andreported via the user interface 28. Likewise, and as is Shown for thepulse E, a subsequent decrease in pulse amplitude is translated into acorresponding decrease in the systolic pressure.

If desired, for a first increase or decrease of the pulse amplitudeabove a predetermined threshold, for example 10%, the measurement cycleof FIG. 6 or 7 can be re-initiated so as to determine absolute valuesfor the new systolic and diastolic pressures. The newly acquired valuesare then employed to calibrate the translation process. For example, anincrease in pulse amplitude of 17% may be found to correspond to a risein the systolic pressure from 130 mm Hg to 150 mm Hg. That is, a 17%increase in pulse amplitude is found to correspond to a 20 mm Hgincrease in the systolic pressure.

In that the venous blood flow is not completely occluded by the methodof sub-diastolic blood pressure measurement described above, this methodcan be utilized for significantly longer periods of time than can themethod of continuous MAP determination described previously.

While the invention has been particularly shown and described withrespect to presently preferred embodiments thereof, it will beunderstood by those skilled in the art that changes in form and detailsmay be made therein without departing from the scope and spirit of theinvention.

What is claimed is:
 1. Apparatus for determining blood pressure withinan artery of a subject, comprising in combination:a cuff adapted forbeing placed around an extremity of the subject; means for controllablypressurizing and depressurizing said cuff, including means for sensing apressure within said cuff; a blood pressure sensor assembly comprising asubstrate and at least one pressure transducer means disposed upon saidsubstrate for being urged against the extremity by said cuff, said atleast one pressure transducer means being capable of sensing an arterialblood pressure oscillation; and means, having inputs coupled to anoutput of said cuff pressure sensing means and also to an output of saidat least one pressure transducer means, for determining a magnitude ofthe systolic blood pressure, a magnitude of the diastolic bloodpressure, and a magnitude of a mean arterial blood pressure of thesubject as a function of measured amplitudes, and relationships betweenmeasured amplitudes, of a plurality of arterial blood pressureoscillations and also in accordance with a sensed pressure within saidcuff at a time of occurrence of each of said plurality of arterial bloodpressure oscillations.
 2. Apparatus as set forth in claim 1 wherein saidat least one pressure transducer means has linear dimensions greaterthan a diameter of the artery.
 3. Apparatus as set forth in claim 1,wherein there are a plurality of pressure transducer means, wherein saiddetermining means includes means for individually measuring said outputof each of said pressure transducer means, and further includes meansfor selecting one of said outputs for use in determining the magnitudeof the systolic, diastolic, and mean arterial pressures.
 4. Apparatusfor determining blood pressure within an artery of a subject, comprisingin combination:a cuff adapted for being placed around an extremity ofthe subject; means for controllably pressurizing and depressurizing saidcuff, including means for sensing a pressure within said cuff; a bloodpressure sensor assembly comprising a substrate and at least onepressure transducer means disposed upon said substrate for being urgedagainst the extremity by said cuff, said at least one pressuretransducer means being capable of sensing an arterial blood pressureoscillation; and means, having inputs coupled to an output of said cuffpressure sensing means and also to an output of said at least onepressure transducer means, for determining a magnitude of the systolicblood pressure, a magnitude of the diastolic blood pressure, and amagnitude of a mean arterial blood pressure of the subject as a functionof a measured amplitude of at least one arterial blood pressureoscillation and a sensed pressure within said cuff at a time ofoccurrence of said at least one arterial blood pressure oscillation;wherein said substrate has a curvature selected to conform to acurvature of the extremity and is adapted for having a concave surfacethereof maintained in contact with said extremity when placed betweensaid cuff and said extremity, wherein said at least one pressuretransducer means is disposed upon said concave surface.
 5. A bloodpressure measuring assembly, comprising:a substrate having apredetermined radius of curvature selected for corresponding to acurvature of an extremity of a subject, said substrate having an innerconcave surface and an outer surface; a plurality of blood pulse sensorelements disposed upon said inner surface of said substrate, said innersurface being a surface that contacts the extremity during the use ofthe assembly, each of said blood pulse sensor elements having a sizethat is a function of a diameter of an artery within the extremity; andan inflatable cuff having a length suitable for wrapping around theextremity for urging said inner surface of said substrate against theextremity.
 6. An assembly as set forth in claim 5 wherein the size ofeach of the blood pressure sensor elements is selected to be larger thanthe diameter of the artery.
 7. Apparatus for determining blood pressurewithin an artery of a subject, comprising in combination:a cuff adaptedfor being placed around an extremity of the subject; means forcontrollably pressurizing and depressurizing said cuff, including meansfor sensing a pressure within said cuff; a blood pressure sensorassembly comprising a substrate and at least one pressure-responsivetransducer disposed upon said substrate for being urged against theextremity by said cuff, said at least one pressure-responsive transducerbeing capable of sensing an arterial blood pressure oscillation; andmeans, having inputs coupled to an output of said cuff pressure sensingmeans and also to an output of said at least one pressure-responsivetransducer, for recording pressure oscillations and corresponding cuffpressures and for determining a magnitude of the systolic bloodpressure, a magnitude of the diastolic blood pressure, and a magnitudeof a mean arterial blood pressure of the subject as a function of saidrecorded pressure oscillations and said corresponding cuff pressures;and wherein said means for controllably pressurizing and depressurizingsaid cuff is thereafter controlled to maintain the cuff pressure withina range of pressures about the determined mean arterial pressure formonitoring the mean arterial pressure of the subject in cooperation withthe operation of said recording and determining means.
 8. Apparatus asset forth in claims 7 wherein said means for controllably pressurizingand depressurizing is controlled to periodically vary the cuff pressureabove and below the determined mean arterial pressure at a rate that isless than the heart rate of the subject.
 9. Apparatus as set forth inclaim 7 wherein said means for controllably pressurizing anddepressurizing is controlled to vary the cuff pressure so as toaccommodate a determined change in the mean arterial pressure. 10.Apparatus as set forth in claim 7 and further comprising means forproviding an indication to an operator of the apparatus of a determinedchange in the mean arterial pressure.
 11. Apparatus for determiningblood pressure within an artery of a subject, comprising incombination:a cuff adapted for being placed around an extremity of thesubject; means for controllably pressurizing and depressurizing saidcuff, including means for sensing a pressure within said cuff; a bloodpressure sensor assembly comprising a substrate and at least onepressure transducer means disposed upon said substrate for being urgedagainst the extremity by said cuff, said at least one pressuretransducer means being capable of sensing an arterial blood pressureoscillation; and means, having inputs coupled to an output of said cuffpressure sensing means and also to an output of said at least onepressure transducer means, for determining a magnitude of the systolicblood pressure, a magnitude of the diastolic blood pressure, and amagnitude of a mean arterial blood pressure of the subject as a functionof measured amplitudes, and relationships between measured amplitudes,of a plurality of arterial blood pressure oscillations and also inaccordance with a sensed pressure within said cuff at a time ofoccurrence of each of said plurality of arterial blood pressureoscillations, wherein said substrate has a curvature selected to conformto a curvature of the extremity and is adapted for having a concavesurface thereof maintained in contact with said extremity when placedbetween said cuff and said extremity, wherein said at least one pressuretransducer means is disposed upon said concave surface.